Safety, Feasibility, and Potential Clinical Efficacy of 40 Hz Invisible Spectral Flicker versus Placebo in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized, Placebo-Controlled, Double-Blinded, Pilot Study
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Safety, Feasibility, and Potential Clinical Efficacy of 40 Hz Invisible Spectral Flicker versus Placebo in Patients with Mild-to-Moderate Alzheimer's Disease : A Randomized, Placebo-Controlled, Double-Blinded, Pilot Study. / Agger, Mikkel Pejstrup; Danielsen, Else Rubæk; Carstensen, Marcus Schultz; Nguyen, N. Mai; Horning, Maibritt; Henney, Mark Alexander; Jensen, Christopher Boe Ravn; Baandrup, Anders Ohlhues; Kjær, Troels Wesenberg; Madsen, Kristoffer Hougaard; Miskowiak, Kamilla; Petersen, Paul Michael; Høgh, Peter.
I: Journal of Alzheimer's Disease, Bind 92, Nr. 2, 2023, s. 653-665.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Safety, Feasibility, and Potential Clinical Efficacy of 40 Hz Invisible Spectral Flicker versus Placebo in Patients with Mild-to-Moderate Alzheimer's Disease
T2 - A Randomized, Placebo-Controlled, Double-Blinded, Pilot Study
AU - Agger, Mikkel Pejstrup
AU - Danielsen, Else Rubæk
AU - Carstensen, Marcus Schultz
AU - Nguyen, N. Mai
AU - Horning, Maibritt
AU - Henney, Mark Alexander
AU - Jensen, Christopher Boe Ravn
AU - Baandrup, Anders Ohlhues
AU - Kjær, Troels Wesenberg
AU - Madsen, Kristoffer Hougaard
AU - Miskowiak, Kamilla
AU - Petersen, Paul Michael
AU - Høgh, Peter
N1 - Publisher Copyright: © 2023 - IOS Press. All rights reserved.
PY - 2023
Y1 - 2023
N2 - Background: Recent studies suggested induction of 40 Hz neural activity as a potential treatment for Alzheimer's disease (AD). However, prolonged exposure to flickering light raises adherence and safety concerns, encouraging investigation of tolerable light stimulation protocols. Objective: To investigate the safety, feasibility, and exploratory measures of efficacy. Methods: This two-stage randomized placebo-controlled double-blinded clinical trial, recruited first cognitive healthy participants (n = 3/2 active/placebo), and subsequently patients with mild-to-moderate AD (n = 5/6, active/placebo). Participants were randomized 1:1 to receive either active intervention with 40 Hz Invisible Spectral Flicker (ISF) or placebo intervention with color and intensity matched non-flickering white light. Results: Few and mild adverse events were observed. Adherence was above 86.1% of intended treatment days, with participants remaining in front of the device for >51.3 min (60 max) and directed gaze >34.9 min. Secondary outcomes of cognition indicate a tendency towards improvement in the active group compared to placebo (mean: -2.6/1.5, SD: 6.58/6.53, active/placebo) at week 6. Changes in hippocampal and ventricular volume also showed no tendency of improvement in the active group at week 6 compared to placebo. At week 12, a potential delayed effect of the intervention was seen on the volume of the hippocampus in the active group compared to placebo (mean: 0.34/-2.03, SD: 3.26/1.18, active/placebo), and the ventricular volume active group (mean: -0.36/2.50, SD: 1.89/2.05, active/placebo), compared to placebo. Conclusion: Treatment with 40 Hz ISF offers no significant safety or adherence concerns. Potential impact on secondary outcomes must be tested in larger scale clinical trials.
AB - Background: Recent studies suggested induction of 40 Hz neural activity as a potential treatment for Alzheimer's disease (AD). However, prolonged exposure to flickering light raises adherence and safety concerns, encouraging investigation of tolerable light stimulation protocols. Objective: To investigate the safety, feasibility, and exploratory measures of efficacy. Methods: This two-stage randomized placebo-controlled double-blinded clinical trial, recruited first cognitive healthy participants (n = 3/2 active/placebo), and subsequently patients with mild-to-moderate AD (n = 5/6, active/placebo). Participants were randomized 1:1 to receive either active intervention with 40 Hz Invisible Spectral Flicker (ISF) or placebo intervention with color and intensity matched non-flickering white light. Results: Few and mild adverse events were observed. Adherence was above 86.1% of intended treatment days, with participants remaining in front of the device for >51.3 min (60 max) and directed gaze >34.9 min. Secondary outcomes of cognition indicate a tendency towards improvement in the active group compared to placebo (mean: -2.6/1.5, SD: 6.58/6.53, active/placebo) at week 6. Changes in hippocampal and ventricular volume also showed no tendency of improvement in the active group at week 6 compared to placebo. At week 12, a potential delayed effect of the intervention was seen on the volume of the hippocampus in the active group compared to placebo (mean: 0.34/-2.03, SD: 3.26/1.18, active/placebo), and the ventricular volume active group (mean: -0.36/2.50, SD: 1.89/2.05, active/placebo), compared to placebo. Conclusion: Treatment with 40 Hz ISF offers no significant safety or adherence concerns. Potential impact on secondary outcomes must be tested in larger scale clinical trials.
KW - 40 Hz
KW - Alzheimer's disease
KW - gamma entrainment
KW - invisible spectral flicker
KW - light-based neurostimulation
U2 - 10.3233/JAD-221238
DO - 10.3233/JAD-221238
M3 - Journal article
C2 - 36776073
AN - SCOPUS:85151044503
VL - 92
SP - 653
EP - 665
JO - Journal of Alzheimer's Disease
JF - Journal of Alzheimer's Disease
SN - 1387-2877
IS - 2
ER -
ID: 369082805